NCT03030677

Brief Summary

The investigators are trying to establish an easy technique for insertion of a catheter for continuous infusion while performing pectoral type 2 (serratus) block, as a post operative pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

January 5, 2017

Last Update Submit

September 7, 2020

Conditions

BreastcancerPhyllodes Breast Tumor

Keywords

pecs blockbreast surgeryultrasound guidence

Outcome Measures

Primary Outcomes (1)

  • successful catheter insertion

    confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound

    during time of performing the block

Secondary Outcomes (2)

  • Number of attempts

    during time of performing the block

  • Duration needed for insertion

    during time of performing the block

Study Arms (2)

Interventional Without Dissectioin

OTHER

confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution

Procedure: Pectoralis II block & catheter without Lidocaine dissectionOther: catheter insertion

Interventional With Dissectioin

OTHER

confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution

Procedure: Pectoralis II block & catheter with Lidocaine dissectionOther: catheter insertion

Interventions

Pectoralis II block & catheter without Lidocaine dissectionPROCEDURE

B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures

Interventional Without Dissectioin
Pectoralis II block & catheter with Lidocaine dissectionPROCEDURE

B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures

Interventional With Dissectioin
catheter insertionOTHER

catheter insertion after Lidocaine dissection

Interventional With DissectioinInterventional Without Dissectioin

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patient scheduled for simple mastectomy
  • Accepted performing the block

You may not qualify if:

  • Patients on anticogulants
  • Chest wall infection
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini Hospitals

Cairo, 11553, Egypt

Location

Related Links

MeSH Terms

Conditions

Phyllodes Tumor

Interventions

CathetersCatheterization

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Equipment and SuppliesTherapeuticsInvestigative Techniques

Study Officials

  • Mohamed Ah Mansour, ass.prof

    Kasr Al Aini Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor, anesthesia department, kasr al aini faculty of medicine, cairo university

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 25, 2017

Study Start

November 1, 2018

Primary Completion

August 31, 2019

Study Completion

November 30, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

EG(1)